Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01642940
Recruitment Status : Completed
First Posted : July 17, 2012
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):
Dimitrios Alexopoulos, University of Patras

Brief Summary:
This is a prospective, randomized, single-center, single blind, investigator initiated, two period study of crossover design. Diabetic patients with Acute Coronary Syndrome (ACS), treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month and subjected to percutaneous coronary intervention (PCI), will be randomized after a baseline platelet reactivity (PR) assessment (24 hours post PCI) while under clopidogrel in a 1:1 ratio to either prasugrel 10mg or ticagrelor 180mg for 15 days followed by crossover directly to the alternate therapy for an additional 15 days without an intervening washout period.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Acute Coronary Syndrome Drug: Prasugrel Drug: Ticagrelor Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Τicagrelor Versus Prasugrel in Diabetic Patients: a Pharmacodynamic Study
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Prasugrel Drug: Prasugrel
Prasugrel 10mg/day

Experimental: Ticagrelor Drug: Ticagrelor
Ticagrelor 90mg twice a day

Primary Outcome Measures :
  1. Platelet reactivity [ Time Frame: 15 days ]
    The primary outcome will be assessed 15 days after the onset of each study drug by the VerifyNow (Accumetrics)assay in platelet reactivity units (PRU)

Secondary Outcome Measures :
  1. Hyporesponsiveness rate (PRU≥230) at the end of the 2 treatment periods [ Time Frame: Day 15 ]
    Hyporesponsiveness rate will be assessed 15 days after the onset of each study drug

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 to 75 years
  • Diabetic patients treated with oral and/or parenteral hypoglycaemic therapy for at least 1 month
  • Patients with acute coronary syndrome subjected to PCI with a baseline PR evaluation 24 hours post PCI while on clopidogrel
  • Informed consent obtained in writing

Exclusion Criteria:

  • Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 30 visit.
  • Pregnancy
  • Breastfeeding
  • Inability to give informed consent or high likelihood of being unavailable for the Day 30 follow up.
  • Cardiogenic shock
  • Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
  • Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 30 days after randomization
  • Requirement for oral anticoagulant prior to the Day 30 visit
  • Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
  • Known hypersensitivity to prasugrel or ticagrelor
  • History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
  • Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm thienopyridine therapy.
  • Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
  • Thrombocytopenia (< 100.000/μL) at randomization
  • Anaemia (Hct < 30%) at randomization
  • Polycytaemia (Hct > 52%) at randomization
  • Periprocedural IIb/IIIa inhibitors administration
  • Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
  • Recent (< 6 weeks) major surgery or trauma, including GABG.
  • Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
  • Concomitant oral or IV therapy with strong CY P3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazana vir, grapefruit juice N1 L/d), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or strong CYP3A inducers (rifampin /rifampicin, phenytoin, carbamazepine).
  • Increased risk of bradycardiac events.
  • Dialysis required.
  • Age ≥ 75 years
  • Weight < 60 Kg
  • Severe hepatic impairment
  • Severe uncontrolled chronic obstructive pulmonary disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01642940

Cardiology Department Patras University Hospital
Patras, Achaia, Greece, 26500
Sponsors and Collaborators
University of Patras

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dimitrios Alexopoulos, Professor of Cardiology, Director of Cardiology Department, University of Patras Identifier: NCT01642940     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-11
First Posted: July 17, 2012    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel Hydrochloride
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Platelet Aggregation Inhibitors